Ascletis Pharma subsidiary Gannex Pharma has dosed the first participant in the US drug-drug interaction (DDI) study of ASC42 to treat primary biliary cholangitis (PBC).
The study, which is anticipated to enrol a total of 12 subjects this month, will conclude in the beginning of the fourth quarter of this year in the US.
ASC42 is a new non-steroidal, selective Farnesoid X receptor (FXR) agonist.
It is also currently being analysed in a Phase II clinical trial in China.
In April this year, Gannex dosed the first subject in a Phase II trial of ASC42 in PBC patients.
This 12-week treatment trial has three active treatment arms assessing 5mg, 10mg, and 15mg doses of ASC42, and a placebo control arm.
It is expected to enrol 100 subjects with insufficient response to, or who are not tolerant to, Ursodeoxycholic acid (UDCA).
The company noted that the DDI study and Phase II clinical trial underway in patients with PBC in China will provide further data to back the upcoming Phase III PBC trials in the US, European Union, and China.
Phase III trials in these regions will begin once the Phase II trial underway in China has concluded.
Ascletis founder, chairman, and CEO Dr Jinzi Wu said: “It only took us two months to complete the first subject dosing after the application of DDI study was approved by the US FDA.
“Gannex is advancing clinical trials of FXR agonist ASC42 in both China and the US to meet the unmet medical needs for patients with PBC.
“We are dedicated to improving the current treatments of PBC and providing more options for patients.”
According to data from a Phase I trial of ASC42 in the US, the therapy showed the potential to become a best-in-class drug candidate for PBC as LDL-C levels were found to be in normal range, without any pruritus occurrence.
A chronic autoimmune cholestatic ailment, PBC often advances to fibrosis and cirrhosis of the liver needing transplantation or causing death.